ACCESS! 2026 Day 1 Recap: Weathering Every Storm to Protect Patient Access
Leaders and luminaries in the generic and biosimilars community descended on Miami for the opening day of ACCESS! 2026, many having braved a historic blizzard slamming the Northeast to reach the sunshine. While the determination of those who made it underscored the industry’s resilience, not everyone was as fortunate. Travel plans for some attendees were dashed by the storm, a reminder that even the best-laid plans can be upended by forces beyond our control. Fitting, perhaps, for a conference squarely focused on navigating uncertainty.
From the political landscape to drug pricing reform to the future of biosimilars, Day 1 delivered a packed agenda of candid conversations and urgent calls to action.
Setting the Stage: The Fight for Sustainability
AAM President & CEO John Murphy III opened the conference with a sweeping assessment of where the industry stands, and set out a vision for where it must go. Generics and biosimilars account for more than 90% of prescriptions dispensed in the United States, saving the healthcare system hundreds of billions annually. Yet that contribution remains under threat from unsustainable pricing dynamics, regulatory bottlenecks, and a reimbursement system that too often fails the companies making affordable medicines possible.
Murphy called on the industry to engage forcefully with policymakers, pointing to early legislative wins as evidence that AAM’s advocacy is gaining traction. But he was candid about headwinds, including tariff instability that threatens to raise costs for manufacturers already operating on razor-thin margins.
Champions of Access Award
The conference recognized the tireless work of advocates advancing the mission of accessible medicines with the presentation of the Champions of Access Award to Tirzeh Duren, President and CEO of the American Consumer Institute. The award recognizes the Institute’s longstanding commitment to policies and initiatives that expand patient access to affordable generics and biosimilars. Tirzeh accepted the award recognizing the contributions of her team and committed to continue the fight in support of a competitive generic and biosimilar marketplace that brings sustained value to patients and the U.S. healthcare system.
Political Landscape: Reading the Room in Washington
On the day of the State of the Union address, a political panel led by AAM Senior Vice President of Government Affairs Mark Ratner offered an insider’s view on the state of the policy environment in Washington. Panelists Cristina Antelo of Ferox Strategies and Kate Hull of Fierce Government Relations dissected White House thinking on drug pricing and affordability, noting that the administration’s appetite for bold action creates both opportunity and risk. The discussion highlighted early legislative wins while warning that tariff instability remains a wildcard. The overarching theme: affordability is the common ground where industry and policymakers can – and must – find alignment.
Gottlieb on AI, FDA Capacity, and the Road Ahead
Former FDA Commissioner Scott Gottlieb joined John Murphy for a wide-ranging fireside conversation. Gottlieb explored the growing role of artificial intelligence in drug discovery and biologics development, describing it as a transformative force, but one that demands a regulatory framework capable of keeping pace. He also warned that staffing challenges and resource constraints are creating bottlenecks in the drug review process, and pointed to the upcoming user fee agreement negotiations as a critical inflection point for the agency.
Employer Perspective: A Fireside Chat with ERIC’s James Gelfand
Executive Director of the Biosimilars Council and AAM SVP of Policy, Alex Keeton, maintained the day’s momentum with a fireside chat featuring James Gelfand, President and CEO of the ERISA Industry Committee (ERIC), a national organization that shapes federal and state health and retirement benefit policies on behalf of the country’s largest employers. The far-reaching conversation connected the day’s dominant themes, including PBM reform and biosimilar adoption, through the lens of employers and plan sponsors who bear the cost of the current system. The takeaway was clear: the push for reform is shared by purchasers and patients alike.
Biosimilars and PBMs: Unfinished Business
Alex Keeton took the stage again after lunch to welcome Brian Reid, founder and principal of Reid Strategic. They discussed the biosimilars market and the persistent role of PBMs in shaping – and often distorting – competition. The panelists noted meaningful progress in biosimilar uptake but stressed that significant barriers to market access remain, from formulary restrictions to reimbursement structures that favor branded biologics. PBM reform emerged once again as a central theme, with the speakers underscoring the urgency of restructuring rebate models and increasing transparency to ensure biosimilars can compete on a level playing field.
Looking Ahead
Day 1 of ACCESS! 2026 made one thing clear: the generics and biosimilars industry is not waiting for the storm to pass – it’s pushing forward. With a charged political environment, evolving trade dynamics, and a healthcare system under pressure to deliver more for less, the stakes have never been higher. Day 2 promises continued momentum with the introduction of new AAM Board Chair Bob Hoffman, a Lifetime Achievement Award presentation, and conversations on the Consolidated Appropriations Act, IQVIA market data, and a fireside chat with HHS leadership.
